NCT03514823

Brief Summary

The investigators seek to understand how reflexes from the breathing muscles influence blood pressure during exercise. Furthermore, the investigators are determining if increasing breathing muscle strength (via inspiratory muscle training) influences the respiratory muscle contribution to blood pressure during exercise.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 2, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2019

Completed
Last Updated

July 26, 2021

Status Verified

July 1, 2021

Enrollment Period

1.2 years

First QC Date

April 18, 2018

Last Update Submit

July 22, 2021

Conditions

Respiratory MuscleBlood PressureExercise CapacitySympathetic Nerve Activity

Outcome Measures

Primary Outcomes (2)

  • VO2 max test

    Using a MedGraphics metabolic cart, the investigators will measure the maximum amount of oxygen that an individual can utilize during exercise. During this test the subject will be asked to exercise to his/her max capacity on a recumbent bicycle while breathing through a mouth piece that is hooked into the MedGraphics computer software.

    Through study completion, an average of one year.

  • Blood Pressure

    Blood pressure will be taken every few minutes during exercise testing using a standard blood pressure cuff to monitor changes in blood pressure.

    Through study completion, an average of one year.

Study Arms (2)

IMT Group

EXPERIMENTAL
Other: Inspiratory Muscle Training (IMT)

No IMT Group

SHAM COMPARATOR
Other: No Inspiratory Muscle Training (IMT)

Interventions

Inspiratory Muscle Training (IMT)OTHER

Inspiratory muscle training (IMT) are breathing exercises used to increase strength and endurance of the respiratory muscles.

IMT Group
No Inspiratory Muscle Training (IMT)OTHER

No inspiratory muscle training.

No IMT Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Healthy participants with no history of cardiovascular, pulmonary, neurologic, orthopedic or other neuromuscular diseases.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55901, United States

Location

Related Links

Study Officials

  • Thomas P Olson

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

April 18, 2018

First Posted

May 2, 2018

Study Start

August 1, 2018

Primary Completion

September 25, 2019

Study Completion

September 25, 2019

Last Updated

July 26, 2021

Record last verified: 2021-07

Locations

US(1)